Label: FIRST AID ONLY FIRST AID/BURN- lidocaine hydrochloride and benzalkonium chloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 30, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • PURPOSE

    First Aid Antiseptic

    External analgesic

  • USES

    First aid to help prevent infection and for the temporary relief of pain and itching associated with minor: •cuts •scrapes •burns.

  • WARNINGS

    For external use only.

    Do not use ▪in the eyes ▪over large areas of the body ▪in large quantities, particularly over raw surfaces or blistered areas ▪if you are allergic to any of the ingredients ▪on deep puncture wounds, animal bites, or serious burns

    • Stop use and ask a doctor if ▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 days ▪a rash or allergic reaction occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.

    Children under 2- Consult a doctor

  • OTHER INFORMATION

    Store in a cool dry area 150 – 250C (590 – 770F)

  • INACTIVE INGREDIENTS

    butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

  • QUESTIONS

    Questions 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    carton label Carton Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY FIRST AID/BURN 
    lidocaine hydrochloride and benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5011(NDC:50382-022)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5011-000.9 g in 1 PACKET; Type 0: Not a Combination Product08/30/2021
    2NDC:0924-5011-0212 in 1 CARTON08/30/2021
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5011-0325 in 1 CARTON08/30/2021
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5011-0110 in 1 CARTON08/30/2021
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5011-04144 in 1 CARTON08/30/2021
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/30/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5011) , repack(0924-5011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5011) , repack(0924-5011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation117825595relabel(0924-5011) , repack(0924-5011)
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